brainstorm cell therapeutics (BCLI) Key Developments

BrainStorm Cell Therapeutics Inc. announced that it has received a Notice of Allowance from Israel's Patent Office for its patent application titled 'Isolated Population of Cells, Methods of Generating Same, and Uses Thereof in the Treatment of CNS Diseases'. This patent is held jointly with Ramot, Tel Aviv University's technology transfer company. This patent claims neurotrophic factor-secreting cells derived from mesenchymal stem cells, methods for producing those cells, and methods of using those cells for the treatment of neurologic diseases.

BrainStorm Cell Therapeutics Inc. announced positive results from preclinical studies of NurOwn™ in the BTBR mouse model of autism. NurOwn™ cells are mesenchymal stem cells (MSCs) that have been induced, under BrainStorm's proprietary methods, to secrete a variety of neurotrophic factors. The BTBR mouse exhibits several stereotypical behavioral characteristics that resemble behaviors seen in autism spectrum disorders, including repetitive behaviors, altered social interactions, cognitive rigidity and impaired adaption to environment. These studies, conducted in collaboration with Professor Dani Offen, PhD, of Tel Aviv University Chief Scientific Advisor to BrainStorm, assessed the ability of NurOwn™ cells to affect the behavior of BTBR mice. Across all the measures, including assessments of repeated self-grooming, social interaction and cognitive rigidity, NurOwn™ cells demonstrated marked behavioral benefits in BTBR mice after a single treatment, as compared to control group, which consisted of BTBR mice treated only with vehicle. NurOwn™ cells performed particularly well in an important assessment of reversal of learning. This test evaluates the time it takes to the mice to maneuver in a water maze after the maze was first learned and then altered. In this cognitive rigidity test, NurOwn™-treated BTBR mice adapted quickly to the new conditions, taking 60% less time than the control BTBR mice to relearn the maze (p=0.016). Notably, the cognitive rigidity and social grooming behavior of the treated BTBR mice were similar to those behaviors observed in a normal mouse strain (C57/BL).

Brainstorm Cell Therapeutics Inc. announced positive final results from its phase 2a clinical trial of NurOwn in amyotrophic lateral sclerosis (ALS) patients, which enrolled 14 subjects at Hadassah Medical Center in Jerusalem. The study achieved its primary endpoint in demonstrating that NurOwn is safe and well-tolerated at doses up to 2 million cells per kilogram administered intrathecally (IT) and 48 million cells administered intramuscularly (IM). Importantly, nearly all subjects in this study experienced clinical benefit from treatment with NurOwn. Of the 12 subjects with three or more months of follow-up, 92% experienced an improvement in the rate disease progression for the three month period after administration of NurOwn, as measured by ALS Functional Rating Score-Revised (ALSFRS) or forced vital capacity (FVC). 50% had an improvement in the slope of the ALSFRS score, and 67% had an improvement in the slope of the percent-predicted FVC. NurOwn slowed the progression of ALS in this study, as indicated by an improving slope of both the mean ALSFRS and mean FVC curves after therapy. On ALSFRS, NurOwn slowed the rate of progression by 45%, from 1.41 points per month during the run-in period to 0.78 points per month for the three months following treatment, and by 57% to 0.60 per month for the six months following treatment. NurOwn had a similarly strong effect on the progressive loss of lung function the rate of decline in percent-predicted FVC was reduced by 73%, from an average of 2.60% per month during the run-in period to just 0.70% per month for the three months after treatment, and by 67% to 0.86% per month for the six months following treatment.

Brainstorm Cell Therapeutics Inc. - Special Call

Dec 22 14

To discuss final results from its phase 2a clinical trial of Nurown in amytrophic lateral sclerosis

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